MEDTEC, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accelerator, linear, medical (IYE) (10)

Premarket Exempt

No Yes

Clear

Positilt™ Baseplate - 00841439100363 Catalog Number : 107010

Device Description : Positilt™ Baseplate

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Positilt™ Baseplate - 00841439100370 Catalog Number : 107020

Device Description : Positilt™ Baseplate

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Multifix™ Baseplate - 00841439100387 Catalog Number : 107063

Device Description : (carbon fiber)

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posifix® Extension - 00841439100400 Catalog Number : 108010

Device Description : Posifix® Extension

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Latch - 00841439100417 Catalog Number : 108011

Device Description : Latch

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SRS Posifix® Extension - 00841439100424 Catalog Number : 108020

Device Description : SRS Posifix® Extension

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Posifix Overlay - 00841439100431 Catalog Number : 108070

Device Description : Non-sterile Posifix Overlay

Device Class :

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Type-S Overlay - 00841439100448 Catalog Number : 108071

Device Description : Non-sterile Type-S Overlay

Device Class :

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Paddles - 00841439100455 Catalog Number : 109012

Device Description : Reusable non-sterile clamp set

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Guide Pins - 00841439100462 Catalog Number : 109013

Device Description : For use with Varian Exact™ Couchtop

Device Class : 2

Duns Number: 103977526

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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